Health Condition 1: F321- Major depressive disorder, singleepisode, moderate
Conditions
Interventions
Intervention1: probiotic: probiotic capsules containing more than 3 billion colony forming units of Lactobacillus helveticus and Bifidobacterium longum each once daily orally for 12 weeks
Control Inte
Sponsors
Department of Health Research, Ministry of Health and Family Welfare, Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Elderly (=60 years) patients of both gender. 2. Patients with a present episode (=2 weeks) of moderate unipolar depression [Montgomery-Åsberg Depression Rating Scale (MADRS) score, 20–34]. 3. Patients who had not received any treatment for the present episode of depression.
Exclusion criteria
Exclusion criteria: 1. Patients who had taken a single dose of any antibiotic within the past 1 month. 2. Patients with psychosis or those with a severe suicidal tendency (according to Beck Scale for Suicidal Ideation). 3. Patients with a cognitive deficit [Montreal Cognitive Assessment (MoCA) score of 4. Patients with diagnosed irritable bowel syndrome or any absorption disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To compare the response rates at 12 weeks (proportion of patients achieving =50% reduction in the MADRS (Montgomery-Åsberg Depression Rating Scale) score from the corresponding scores at baseline) between the two groups.Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| • To compare the dosage of background antidepressants between the two groups at 12 weeks.Timepoint: 6, 12 & 24 weeks | — |
Countries
India
Contacts
Public ContactDr Abhinaba Ghosh
ICMR
Outcome results
None listed